Witch Hazel by Hydrox Laboratories WITCH HAZEL liquid

Witch Hazel by

Drug Labeling and Warnings

Witch Hazel by is a Otc medication manufactured, distributed, or labeled by Hydrox Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Witch Hazel 86%

Purpose

Astringent

Uses

For relief of minor skin irritations due to insect bites, minor cuts, minor scrapes.

Warnings

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to the affected area as often as necessary. When using this product, avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days.

Inactive ingredient

Alcohol 14% by volume

SPL UNCLASSIFIED SECTION

DIST. BY:
HYDROX LABORATORIES
825-B Tollgate Rd. Elgin, IL 60123

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Personal Care

FreshMoment

Witch Hazel

Natural Astringent
Cleans and Refreshes Skin
No Artificial Fragrance
or Dyes

MADE IN USA

16 FL. OZ. (473mL)

INGREDIENTS AND APPEARANCE

WITCH HAZEL 
witch hazel liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10565-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34)	Witch Hazel	86 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10565-040-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/21/2011

Labeler - Hydrox Laboratories (025164302)

Registrant - Hydrox Laboratories (025164302)

Establishment
Name	Address	ID/FEI	Business Operations
Hydrox Laboratories		025164302	MANUFACTURE(10565-040) , label(10565-040) , pack(10565-040)